scholarly journals NARROW THERAPEUTIC INDEX DRUGS;

2017 ◽  
Vol 24 (04) ◽  
pp. 596-606
Author(s):  
Huma Ali ◽  
Farya Zafar ◽  
Ahmed Shaukat ◽  
Shazia Alam ◽  
Umer Ali ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Study Design ◽  
Study Participant ◽  
Therapeutic Index ◽  
Narrow Therapeutic Index ◽  
High Incidence ◽  
Hospital Stays ◽  
Clinically Significant ◽  
Narrow Therapeutic Index Drugs ◽  
Selection Of

Introduction: There are several clinically significant outcomes of drug-druginteractions (DDIs) which have been classified as one of the serious forms of adverse drugreactions that may lead to prolongation of hospital stays along with severe cases of mortality andmorbidities. It may cause due to the selection of two or more interacting drugs to be prescribedto patient. Objectives: Therefore it is indispensable to attain a collective level of therapeuticdecision making so that any potential DDIs can be minimized that ultimately turn out to be safeand beneficial to patient. Study Design: The current study is based upon surveys to evaluateutilization of medications that have a narrow therapeutic range with high incidence to developDDIs and to access the knowledge, attitude as well as practice of using such drug productsin relation to these facts, though very few such studies have been identified, yet the relevantdata is insufficient locally. The study design was selected to be qualitative and cross sectional.Period: January 2016 till August 2016 in Karachi, Pakistan. Settings: The questionnaire waswell constructed for physicians, pharmacists as well as nurses who were selected as theparticipant of the study and a former consent from the respondents was obtained. Method:Coefficient of spearman correlation & Cronbach’s α values were calculated in order to validatethe questionnaire (α = 0.927 and p = 0.918). The information based on practice along withdemographics of study participant was included as first segment of questionnaire while theirknowledge regarding drug interactions was included as second part. Mean scores werecalculated and responses were analysed by ANOVA in relation to the knowledge of membersrelating to drug interactions of vancomycin, warfarin and valproic acid. Results: Mean scores ofperception were found in order of 1.590.16, 1.549.02 and 2.020.83 for physicians, pharmacistsand nurses. No significant differences were observed between physicians and pharmacistscohorts in identifying the drug interactions whereas noteworthy variations were observed inthe group of nurses (p < 0.05). Conclusion: Such investigations are vital in their prospect tohighlight the importance for the design, implementation and monitoring of an effectual toolfor the guidance of various healthcare members involved in identification and management ofDDIs. Furthermore, results also signify the need of sophisticated support systems for valuableclinical judgments.

scholarly journals Assessing Bioequivalence of Antiepileptic Drugs: Are the Current Requirements too Permissive?

2014 ◽  
Vol 17 (2) ◽  
pp. 220 ◽  
Author(s):  
Camila F Rediguieri ◽  
Jorge L Zeredo
Keyword(s):  
Antiepileptic Drugs ◽  
Geometric Mean ◽  
Therapeutic Index ◽  
Maximum Deviation ◽  
Strongly Correlated ◽  
Average Difference ◽  
Narrow Therapeutic Index ◽  
Subject Variability ◽  
Clinically Significant ◽  
Narrow Therapeutic Index Drugs

Purpose: In order to evaluate the permissiveness of current bioequivalence requirements for antiepileptic drugs we investigated how accurate Cmax and AUC0-t of generic antiepileptic drugs approved in Brazil are in comparison to reference products. Methods: Data collected from assessment reports of approved bioequivalence studies archived in the Brazilian regulatory agency in 2007-2012 were: geometric mean ratios and 90% confidence intervals (CI) for Cmax and AUC0-t, intra-subject variability (CV) of Cmax and AUC0-t and number of subjects. Results: The average difference in Cmax and AUC0-t between generic and reference products was 5% and 3%, respectively. Maximum deviation from 1.00 of the CI of Cmax can achieve 15-20% (demonstrated in 27% of studies); for AUC0-t, 25% of studies showed the deviation can be >10%. All studies that used adequate number of subjects for a 90% CI of 0.90-1.11 complied with it for AUC0-t, except one of carbamazepine, but only 33% complied with it for both AUC0-t and Cmax. The CV was strongly correlated to the maximum CI deviation for AUC0-t (CV of approximately 15% corresponding to deviation of 10%). Studies that presented maximum CI deviation ≤ 10 % together with CV ≤ 15% for AUC0-t represented 65% of the total. Weaker correlation was observed for Cmax and no correlation was seen between maximum CI deviation and number of subjects. Conclusions: Modification in legislation for bioequivalence of antiepileptic drugs is suggested, not only with constraint of AUC0-t 90% CI to 0.90-1.11, but also with limitation of the CV to 15%, as to assure similar variance in pharmacokinetics and diminish the risk of critical plasma-level fluctuation when switching between generic and reference formulations. Although most generics presented differences ≤ 10% in AUC0-t compared to their references, some narrow therapeutic index drugs displayed differences that could be clinically significant after product substitution.  This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Nano optical and electrochemical sensors and biosensors for detection of narrow therapeutic index drugs

2021 ◽  
Vol 188 (12) ◽  
Author(s):  
Omid Heydari Shayesteh ◽  
Reza Mahjub ◽  
Akram Ranjbar ◽  
Katayoun Derakhshandeh ◽  
Mahdi Jamshidi
Keyword(s):  
Electrochemical Sensors ◽  
Therapeutic Index ◽  
Narrow Therapeutic Index ◽  
Narrow Therapeutic Index Drugs

scholarly journals Estimated Manipulation of Tablets and Capsules to Meet Dose Requirements for Chinese Children: A Cross-Sectional Study

2021 ◽  
Vol 9 ◽  
Author(s):  
Liwen Zhang ◽  
Yan Hu ◽  
Panpan Pan ◽  
Chengtao Hong ◽  
Luo Fang
Keyword(s):  
Family Care ◽  
Therapeutic Index ◽  
Cross Sectional Study ◽  
Narrow Therapeutic Index ◽  
Cross Sectional ◽  
National Medical ◽  
Care Givers ◽  
High Incidence ◽  
Drug Doses ◽  
Dose Form

Objectives: To estimate the frequency of manipulations of all tablets and capsules prescribed for children in a teaching and tertiary children's hospital in China over the course of 1 month. Moreover, hypothetical reduction of manipulation according to the availability of low-strength tablets/capsules licensed by the Chinese National Medical Products Administration (CNMPA) was evaluated.Methods: Information on all tablets and capsules prescribed in the hospital from March 17 to April 16, 2019 was collected. It was assumed that tablets or capsules were manipulated if the prescribed dose would have required only a proportion of the intact dose form. Manipulation typically includes splitting or crushing tablets, opening capsules and dispersing in water, or combinations of these method. Moreover, we defined an “avoidable manipulation,” when the dose could be rounded and/or when alternative products with a reduced strength or in liquid formulation were available in the hospital, and a “inappropriate manipulation,” which involved manipulated medications with a direct contraindication for any manipulation, such as those with a narrow therapeutic index or hazardous ingredients, or modified release dosage-forms. The frequencies of total, avoidable, and inappropriate manipulation were estimated, along with the hypothetical reduction of manipulation according to the availability of CNMPA-approved drug doses.Results: A total of 17,123 prescriptions for 142 medications were identified to have required a manipulation among 78,366 prescriptions administered during the study period, with 43 different proportions of subdivisions, ranging from a 19/20 to 1/180 product strength reduction. Half, quarter, and trisection were the most common subdivisions administered. Overall, 19% of the manipulated prescriptions were determined to be avoidable, and 19% of the manipulations involved medications with a clear recommendation to not manipulate. In addition, 21% of the manipulated prescriptions could have been potentially avoided if all of the approved preparations with the lowest strength would have been available at the hospital. Any manipulations undertaken were carried out by pharmacists and family care givers.Conclusions: More than 20% of tablets and capsules prescriptions need manipulated, included a high incidence of avoidable and inappropriate manipulation.

Sign in / Sign up

Export Citation Format

Share Document